A place for a tired old woman to try to figure things out so that the world makes a bit of sense.

Saturday, July 10, 2010

More On Avandia And The FDA

Last week, I took a look at the latest news on some unholy side effects of the glucose lowering drug Avandia. The FDA has also been taking a look, a long hard one, and the agency might finally be gearing up to take the drug manufactured by GlaxoSmithKline off the market.

A federal drug official on Friday dealt a severe blow to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.

The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.

Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Dr. Marciniak wrote.

The detailed report could prove crucial next week, when a panel of experts will meet to consider whether to recommend to the F.D.A. that the manufacturer, GlaxoSmithKline, withdraw Avandia from the market or restrict its sale. [Emphasis added.]

The clinical trial was paid for by GlaxoSmithKline, which apparently is not unusual. The FDA doesn't have the budget to run such trials. What is unusual is the strong suspicion that the drug-maker might have improperly influenced the reportage of that trial, resulting in the omission of some of the critical findings.

Dr. Marciniak works in a section of the FDA which has been supportive of Avandia all along. His about face on the drug doesn't bode well for next week's meeting of the panel which advises the FDA on such issues.

And the pharmaceutical company's response to this latest assessment?

Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said the study demonstrated that Avandia is safe and added, “The Record study was conducted according to good clinical practices and the data are reliable.”

No surprise there, eh?

It's time to take Avandia off the market before more people die from taking it.